Medical

Overview

As medical devices become more connected, addressing the issues of runaway healthcare costs and healthcare access, robust, reliable and secure performance in medical device design are defining differentiators. For over 30 years, QNX® has been providing a full-featured, multi-core development platform that exceeds the most demanding requirements for reliability, performance, data safety, and security. With QNX's IEC 62304 conforming OS, field-proven portfolio of pre-integrated technologies, solutions, and a broad partner ecosystem, developers can focus on their IP in application design and functionality, leaving the platform heavy lifting to us.

Explore the Solution

OS FOR MEDICAL; IEC 62304 COMPLIANT OPERATING SYSTEM

Choosing the right realtime operating system (RTOS) partner can simplify certification processes, can provide clear product differentiation and help to reduce your risks as well as realize significant bill of materials (BOM) and cost advantages.

Further reductions in costs and efforts can be achieved in a project by leveraging the QNX® OS for Medical that is 3rd party certified and declared compliant to IEC 62304. The burden of compliance is lifted from the medical device manufacturer and proof is provided directly from QNX through certificates of conformance and extra support documentation. Documents such as Hazard and Risk Analysis, User Responsibility Guide, and Technical Safety Case documents are available to aid in your regulatory submission.

CONNECTIVITY

There is great disparity between medical devices today and what healthcare enterprise customer want. Software comes from the OS vendor and many ecosystem vendors that need integration. This all leads to workflows that are manually and archaic, handwritten paper and Post-it notes, SMS and pagers. The healthcare world would like to see medical devices better interconnected with IT systems resulting in automation, analysis that spans multiple discrete systems, increased compliance and adherence.

CYBERSECURITY

Patient security is an important issue but upholding patient safety is of utmost concern to medical device manufacturers.

A connected medical device is a vulnerable and exposed medical device. Medical devices are the key pivotal points of attack in most hospital networks. They represent visible points of vulnerability and are the hardest endpoints to remediate. Any software beyond a patch provided by the manufacturer might negatively impact FDA approval, but worse compromise patient security and safety.

To address the ever-increasing security threats facing medical device manufacturers, QNX has advanced security mechanisms that are built directly into the QNX operating system that protect devices from malicious attacks. These can be used to ensure that all processes, including drivers and filesystems, execute in user-mode, greatly reducing the ability of compromised processes. Further, it is possible to divide the filesystem into encrypted domains, as well as to randomize the address space layout for further protection against malicious intent.

The security attack surface of the system can be further reduced by utilizing a unique ability to control settings that govern and protect which operations a process can perform, with granularity down to the system-call level. As a result, embedded developers no longer have to give processes root permissions and access to the entire system in order to gain access to necessary system resources.

Beyond the OS, we can provide our customers with elliptical curve cryptography IP offering FIPS 140-2 levels of security. This is a minimum requirement when servicing the veteran’s administration or various branches of the military.

SPEED YOUR TIME TO MARKET

Accelerate your new product introduction and allow your experts develop and fully leverage your IP while allowing QNX to do the heavy lifting by supporting the operating system. Development life-cycle is paramount. You can forget about the need for finding, sourcing, configuring, and compiling your open source software by leveraging QNX OS for Medical; effectively jump start your development and eliminate risks.

Further downstream, unlike open source OSes there is no need to worry about managing asynchronous patches affecting a majority of your source base. This takes time, costs real dollars and consumes real resources. Make it across the chasm and don’t concern yourself with the burden of software maintenance and focus your ‘IP’ or Intellectual People, on yoursecret sauce.

TOTAL COST OF OWNERSHIP

The total cost of ownership for a project consists of many factors that may not be immediately apparent. A simple decision based on a shallow analysis of the cost of obtaining and licensing the source code is insufficient. When evaluating an OS for a medical device it is critical to compare the cost of such big-ticket items as development cost, maintenance cost, support cost, and opportunity cost.

The Linux operating system provides for open access to its source code, this has led companies to initially choose Linux as a viable development platform, on the perceived basis that its cost is less than commercial alternatives. Anyone considering using Linux for a medical device project needs to be prepared to make an informed decision about the relative merits over choosing a stable and certified platform like QNX.

A big differentiator that the QNX operating system offers is clean intellectual property (IP). The origin of the entire OS is known and transparent. Unlike open source software where the lack of traceability can bring sublicensing and liability issues to the forefront.

QNX offers the means to support issues, custom engineering, open source integration and license compliance all to help you get back to what you do best, your own application software.

Hypervisor

The QNX® Hypervisor is a realtime Type 1 virtualization solution for realtime connected embedded systems. By using the QNX Hypervisor, embedded developers can consolidate multiple operating systems onto a single compute platform or system-on-a-chip (SoC) to reduce the cost, size, weight and power of their system designs while enforcing clean separation and isolation of critical and general-purpose applications.

The QNX Hypervisor lets system architects and device manufacturers safely and securely isolate multiple operating systems from one another on a single hardware platform to greatly reduce overall product costs.

Graphics / Human-machine interfaces (HMI)

The QNX OS for Medical provides a level of graphics and mobile techniques offered by no other commercial RTOS.

QNX delivers a compositing windowing system which integrates multiple graphics and user interface technologies into a single scene. This scene is then rendered into one image that is associated with a display. This allows the designer to use the most appropriate graphics technology that corresponds with the image, be it video, OpenGL® ES, HTML5, or Qt 5.

With the QNX OS for Medical, developers can build graphically-rich, compelling user interfaces (UIs) using built-in, high performance OpenGL ES-based transitions. They can also support multi-touch displays and gestures, and render images from Qt, HTML5, video, and other technologies through a single compositing windowing system, which integrates multiple graphics and UI technologies into a single scene.

Screen integrates multiple graphics and user interface (UI) technologies into a single scene. This scene is rendered into one image that is associated with a display.

Multi-touch input control

QNX supports the multi-touch graphical displays that are in wide use. The Input Events library has been extended to support multi-touch screens. The Gestures library provides gesture recognizers to detect gestures through touch events that occur when you place one or more fingers on a touch screen.

Video capture

The video capture framework enables applications to capture frames from a video input source and display them using the Screen compositing windowing system.

With the QNX SDK for Apps and Media, developers can leverage the power of open, mobile application development, including a multitude of open JavaScript application frameworks and tools. Using HTML5 as a user interface can dramatically reduce the time required to develop user interfaces versus traditional embedded user interface toolkits.

Optimized HTML5 engine and web browser

The HTML5 engine is the foundation for HTML5-based user interfaces. It is based on the WebKit open source web browser engine, which QNX has optimzed for embedded environments, and to which QNX has added numerous capabilities to provide a full-featured web browser to offer the fastest HTML5 rendering performance and broadest support for HTML5 standards.

High availability manager

High availability is not optional for life-critical medical devices. The QNX framework provides critical process monitoring and restarts without the need to reboot, ensuring 100% device uptime.

Adaptive partitioning

Adaptive partitioning offers dynamic scheduling capabilities to enforce guaranteed service availability as well as optimize device performance. This is particularly important when integrating third party software – which is often CPU intensive. By eliminating wasted, unused cycles created by fixed partitioning designs, adaptive partitioning speeds time to market and does away with the complex task-starvation problems that typically arise during integration.

Networking

QNX Software Systems offers one of the most comprehensive networking solutions for an embeddable RTOS with capabilities typically reserved for desktops and servers. The native distributed processing supports complex distributed systems in which multiple devices seamlessly share resources and communicate without custom protocols. The networking ecosystem offers support for all forms of wireless networking from point-to-point connections such as Bluetooth and ZigBee, to peer-to-peer networking like WiFi (802.11) – without compromising safety or security of sensitive patient data.

As outlined in the Health Insurance Portability Accountability Act (HIPAA) in the United States, patient data must be stored and transmitted in ways that maintain strict data privacy measures. QNX provides support for a number of authentication and security protocols including: WEP, WPA/WPA2, Radius, 802.1x, SSL, IPSec, IPv6, and NAT.

Integrated development environment

The QNX® Momentics® Tool Suite is an Eclipse-based IDE that is tightly integrated with many sophisticated tools for debugging and optimizing code during different phases of the software development cycle. Innovative profiling tools provide insight into system and application behavior - facilitating code coverage testing, performance profiling, debugging, and source-level verification. Reusable software assets and industry standard tools allow for system scalability and portability both in the short-term and down the road.

IEC 62304 Software Life-Cycle for Medical Devices

The QNX® OS for Medical is 3rd party certified compliant with the requirements of International Electrotechnical Commission (IEC) standard 62304 Software Life-Cycle for Medical Devices. IEC 62304 is an international standard that provides a framework of life cycle processes with activities and tasks, and incorporates risk management requirements as outlined in IEC 14971.

FDA

With QNX, industrial customers have the assurance of using a software architecture proven in thousands of mission-critical and life-critical environments, including FDA Class III medical devices. In fact, QNX Software Systems has passed all audits by medical device companies seeking FDA approval for their QNX technology-based products.

IEC 61508 Safety Integrity Level 3 (SIL 3)

The QNX® OS for Safety is certified to meet the requirements of International Electrotechnical Commission (IEC) standard 61508 Safety Integrity Level 3 (SIL3). IEC 61508 is an international standard for the functional safety of electronic systems, and offers a very high level of reliability and risk reduction when used in safety-critical systems for transportation, energy generation, process control, and other industries. Meeting the IEC 61508 requirements involves a systematic assessment by an independent certification body.

ECOSYSTEM PARTNERS

Medical device manufacturers operate in a challenging environment filled with stringent regulatory requirements and industry pressures. Medical device manufacturers must develop increasingly complex devices in timelines that are more typical of consumer-grade electronics, but difficult to meet in a regulated industry. In order to meet these challenges, extensive ecosystem partnerships are increasingly leveraged to meet the performance and time driven demands in medical device development.

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